Senior Regulatory Wrriter
- Experience Level
Senior Medical (Regulatory) Writer
Open pay rate
6 month contract
As the Senior Medical Writer you will research, create, and edit all documents associated with clinical research.
Responsibilities will also include: acting as primary client contact for medical writing projects, working with other departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff.
Author Clinical Documents
- Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to:
Briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy.
- Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.
- Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
- Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.
Document Project Management
- Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.
- Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to client guidelines/SOPs. Distribute final documents to project team and client.
- Attend and complete mandatory, corporate, project-specific, and departmental training as required.
- Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department.
- Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
- Excellent interpersonal, negotiation, verbal, and written communication skills.
- Motivation to work consistently in a fast-paced, rapidly changing environment.
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.
- Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity.
- Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved.
- Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
Knowledge and Experience:
- Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
- Extensive clinical/scientific writing skills.
- Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar.
- Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).
- Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.